© ISO Management Systems, www.iso.org/ims                                                                                 ...
© ISO Management Systems, www.iso.org/ims        SPECIAL REPORTWhat’s new?                                Clause in       ...
© ISO Management Systems, www.iso.org/ims                                                                                 ...
© ISO Management Systems, www.iso.org/ims        SPECIAL REPORTThis is likely to prompt ques-                             ...
© ISO Management Systems, www.iso.org/ims                                                                                 ...
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22000 implementation ims_06_03

  1. 1. © ISO Management Systems, www.iso.org/ims SPECIAL REPORT ISO 22000 From intent to implementation How close is the intent of ISO 22000:2005 and its implementation by users ? An expert who took part in its design and development has reviewed feedback from early users and gives some pointers to tackling the issues they raise. ISO 22000:2005, Food safety in any of the quality or food These innovations mainly management systems – Require- safety management systems relate to the interpretation, ments for any organization in standards used so far by com- consistency and thorough- the food chain is the first man- panies in the food chain (e.g. ness of the HACCP method agement system standard on ISO 9001, BRC, IFS, DS 3027 of controlling food safety haz- food safety to go beyond the or others). Table 1 (overleaf) ards. Indeed, ISO 22000 is the by Didier Blanc recommendations put forward lists and interprets the key new first standard that not only in 1993 by the Codex Alimen- elements. endorses the Codex Alimen- Author Didier Blanc is founder tarius Commission. Inevita- tarius recommendations, butand director of ProCert, a provider bly, the arrival of this brand also attempts to fill the gapsof training and certification in ISO new standard with its updat- and inconsistencies brought to 9001, ISO 14001 and ISO 22000 ed approach is accompanied light by 13 years of accumulat- management system standards. by issues of interpretation ed experience with HACCP. and how to meet its require- He is a veterinary surgeon ments.specialized in food hygiene, and a member of Working Groups WG 8 and WG 11 of ISO Technical Com- mittee ISO/TC 34, Food products, ISO 22000 goes beyond responsible for developing ISO the food safety22000:2005, Food safety manage- recommendations ment systems – Requirements for put forward in 1993any organization in the food chain, by the Codex Alimentarius and ISO/TS 22003, Food safety Commission management systems – Require- ments for bodies providing audit and certification of food safety The main interpretation and management systems. implementation challenges Dr. Didier Blanc, Director, ProCert, revolve around requirementsCH-1015 Lausanne 15, Switzerland. that did not appear in the 12 Tel. + 41 79 337 51 39. Hazard Analysis and Critical Fax + 41 21 693 87 20. Control Point (HACCP system) E-mail procert@epfl.ch application steps described in Web www.procert.ch the Codex Alimentarius, nor ISO Management Systems – May-June 2006 7
  2. 2. © ISO Management Systems, www.iso.org/ims SPECIAL REPORTWhat’s new? Clause in New element Investing in skills the standardFigure 1 illustrates the links In a nutshell, while the require-between ISO 22000 and the 12 ments for means often involveHACCP steps and highlights 5.5 Responsibility and authority for : organizing the team’s investment in infrastructure,the stages that have been add- Food safety team training and work ; ensuring the implementation and the obligation to achieveed (broken outline), or signifi- leader updating of the system ; reporting to management ; results leads rather to invest- communicating.cantly altered and consolidat- ing in manpower, in the skillsed (yellow background). 5.6 External communication relating to food safety haz- of the HACCP team and its Communication ards throughout the food chain (upstream and down- leader, and in the staff thatThese innovations apply as stream) ; impact on the control of foodmuch upstream – the require- Internal communication to ensure that the HACCP team product safety.ment for the selection andimplementation of appropri- is informed in real-time of all changes (e.g. raw mate-ate prerequisite programmes rials, facilities and installations, recipes, requirements, etc.) likely to affect the system.(PRP’s) 1), before proceeding to ISO 22000 stateshazard analysis – as to the core 6.2 The requirements of (demonstrated) competence of requirements in terms ofof the HACCP system itself : Human resources the HACCP team members and the staff having an results rather than meanshazard analysis, selection, vali- impact on food safety.dation and monitoring of ade- 7.2 The company should itself select and implement appro-quate control measures. Prerequisite priate good hygiene practices (instead of merely apply- programmes (PRP’s) ing those imposed upon it). However, corporate cultureA generic requirements-based limitations often arise as soonstandard designed for certifi- 7.4.2 Taking into account the various stages in the food as the qualification and empow-cation purposes cannot pro- Hazard identification chain (primary production, processing, distribution) erment of staff are involved,vide examples or recommen- and determination where hazards can occur ; of acceptable levels while many companies do notdations, so I will provide some Determination of acceptable levels in the finished have the resources to employhere. In addition, the systems product. highly trained HACCP man-approach of ISO 22000 states 7.4.4 Selection of (combinations of) control measures associ- agement.requirements in terms of results Selection and ated with hazards assessed as requiring control ;rather than means. In addition to the financial assessment of Assessment of the effectiveness of control measures ; resources needed to fund aAlthough this approach, suc- control measures Method for assigning these (combinations of) control team of competent managerscessfully applied in ISO 9001 measures either to the HACCP plan (“conventional ” and specialists, it may proveand ISO 14001, has been wide- CCP), or to operational PRP’s (new concept). difficult to find appropriately supported by representa- training and recruit experts,tives of the food industry, it 7.5 Establishment of a monitoring system (procedures, and develop the necessarycan prompt questions such as Establishing responsibilities, corrective actions) for the (combi- the operational nations of) control measures assigned to the opera- experience and skills on thethe following: prerequisite tional PRP’s. job. Nevertheless, an organiza-• What do I have to do ? tion can find a solution suited programmes (PRP’s)• What are the baselines ? to its size and circumstances 8.2 Prior validation of the effectiveness of the (combina- by measures such as the fol-• Can I have examples ? Validation of tions of) control measures to ensure observance of the lowing : control measure predefined acceptable level for the relevant hazard.• How will I validate my combinations choices ? 8.4.2 Systematic review of individual results of the plan and• How can I be sure not to go Evaluation of verification (e.g. implementation of operational PRP’s 1) Prerequisite programme (PRP) : basic conditions and too far, or not far enough ? individual verification and CCP’s, compliance with acceptable levels, and anal- activities that are necessary to results ysis of products and services, etc.). maintain a hygienic environment throughout the food chain suitable 8.4.3 Analysis and overall review of the implementation, oper- for the production, handling and Analysis of results of ation and efficiency of the system and of the trends in provision of safe end products and Table 1 – Key innovations verification activities terms of hazard control, with management reporting. safe food for human consumption. of ISO 22000 (ISO 22000).8 ISO Management Systems – May-June 2006
  3. 3. © ISO Management Systems, www.iso.org/ims SPECIAL REPORT– exchanging or sharing HACCP team members, and functions such as inter- Figure 1 – ISO 22000 and Codex 7.3.2 Food safety team  1  nal auditing and data anal- Alimentarius ysis, among several compa- – What’s 2 nies; new ? 7.3.3 Product characteristics– integrating supplier or cli- For French  ent experts into the team, to bring in hazard control speakers… 3 expertise from other lev- 7.3.4 Intended use els in the food chain; French speakers can find – using e-learning when the further help on ISO 22000 required vocational training interpretation and imple- 4 is not available in appropri- mentation in Didier Blanc’s Flow diagrams ate timeframes, locations or book ISO 22000, HACCP et  quality 2). sécurité des aliments – Recommandations, outils, 7.2 Prerequisite programmes (PRP) 5 or Good hygiene practices (GHP)Some examples FAQ et retours de terrain Description of (ISO 22000, HACCP and food process steps and control measuresOne of the difficulties in com-  safety – recommendations,plying with the requirements tools, FAQ’s and user feed-of a standard is to find a start- 6.aing point on which to build the back), on which this article 7.4.2 Hazard identification andimplementation. Examples is based. determination of acceptable levels can help set the right courseand boost confidence in the His book illustrates theimplementation process. Two principles of the new Inter- 6.bsuch examples are described 7.4.3 Hazard evaluation national Standard with hereafter. practical examples, and is based on answers to the mostSelection of control frequently asked questions 6 c-7 7.4.4 Selection and evaluationmeasures (FAQ’s) on food safety man- of control measures Clause 7.4.3, Hazard assess- agement systems, and onment of ISO 22000 (see Figure the management tools he 8-9-101) serves to determine which developed in over 20 years’ 7.5 Establishment 7.6 Establishmentof the potential hazards iden- food safety experience. of operational PRP’s of HACCP plantified require specific controlmeasures. To ensure such con- ISO 22000, HACCP et sécuritétrol, the standard requires the des aliments – Recomman-selection of (or combination 8.2 Validation of combinations dations, outils, FAQ et retoursof) control measures (clause of control measures de terrain (ISBN 2-12-445311- 7.4.4, Selection and assess- 4) is published in French byment of control measures). Association française de nor- 11 malisation (AFNOR), 7.8 Verification planning 2) See, for example, the HACCP 350 pp, price 42.65 euros,and ISO 22000 courses on theI-Cube Academia platform devel-oped by Liège University,Belgium, and Lausanne Polytechnic, available from www.boutique.afnor.fr Elements added to Codex Alimentarius  HACCP steps according to Codex AlimentariusSwitzerland – www.i3academia.com Significantly altered and consolidated, compared to Codex Alimentarius ISO Management Systems – May-June 2006 9
  4. 4. © ISO Management Systems, www.iso.org/ims SPECIAL REPORTThis is likely to prompt ques- fears by providing a list of pos-tions such as : sible approaches. These are presented in Table 2 in the• Where do these control form of a systems approach measures come from ? to implementation based on• How do they differ from existing validations within a PRP’s ? small company in a specific• Should they be selected business sector. from the PRP’s – in which case I doubt the value of this additional requirement Where to start? since the HACCP measure Once one is convinced that ISO is already in place – or else- 22000 is the best approach to where ? controlling impacts on the safe- ty of food products, the inevita- ble question arises, “Just where An organization can find do I start?”a solution suited to its size Much will depend on the com- and circumstances pany’s certification status in terms of ISO 9001, BRC, IFS, etc. Indeed, certain principlesThe required control measures common to all managementcan be selected either : system standards will have already been assimilated –– from an organization’s PRP’s e.g. control of documents and (e.g. the slicing sequence of Validation of control a cross-contamination haz- measures Product ard between cooked meat preparation and air-dried Clause 8.2, Validation of con- Hazard to be controlled meat products, or a refrig- trol measure combinations, Control measure(s) eration chain in the case of basically a new requirement fresh products) ; introduced by ISO 22000 that Applicable Validation methods Comments relates to the control meas- yes/no– beyond the PRP’s, by intro- ures addressing hazards hav- ducing additional, more Third-party scientific validation ing been assessed as needing advanced technology (e.g. control, control measures that Historical knowledge laminar flux, air process- must then be validated before ing, x-ray detection) ; Simulation of production conditions being implemented. This might– outside the PRP’s relat- prompt prospective users to Collection of data in normal declare, “But I have neither the production ing to that specific busi- ness sector, using measures human nor financial resourc- Admissible in industrial practices which belong to another es to perform scientific val- idations! Isn’t the standard Statistical programmes level in the food chain (e.g. good agricultural or animal designed mainly for large and Mathematical modelling health practices, integrated wealthy companies alone, and not for the small players?” Conclusion : farming, or EurepGAP cer- internal validation needed ? tification required by the ISO/TS 22004, Food safety If so, following which method ? food industry of its suppli- management systems – Guid- ers). ance on the application of ISO Table 2 – Need for and methods of, validating control measures 22000:2005 can help allay such according to ISO/TS 2200410 ISO Management Systems – May-June 2006
  5. 5. © ISO Management Systems, www.iso.org/ims SPECIAL REPORT records, policy, internal audit- ring, improvement measures, Sources of help mmanagement review.In addition to the official guidance provided control measures that theby ISO in ISO/TS 22004, examples of food hazard analysissafety management-related frequently asked identifies as necessary toquestions (FAQ’s) are available on the control identified hazards toauthor’s ProCert Web site – www.procert.ch – acceptable levels, and whichwhich also welcomes new questions in are not otherwise managed byEnglish, French and German. A sample the HACCP plan;question and answer follows. • a HACCP plan to manage thoseQuestion control measures that the hazard analysis identifies asI see no difference between PRP (or GMF/ necessary to control identifiedGHP’s) and control measures. For me, PRP’s hazards to acceptable levels,are measures to control existing hazards, and which are applied atotherwise they have no purpose. Moreover, critical control points (CCP’s).control measures associated with hazards willalways be selected from among the PRP’s. AnswerRecommendations of ISO/TS 22004: In view of the clarifications provided by The key is to correctly man- ISO/TS 22004, the answer seems to be age HACCP procedures inISO/TS 22004 provides the following twofold : conjunction with the addition-clarifications in this respect : al requirements of ISO 22000 1) Yes, strictly speaking PRP’s are control which, while introducing con-ISO 22000 reorganizes the traditional con- measures, even though in practice it is sistency, nonetheless requirecept of dividing control measures into two recommended not to designate them as some effort to assimilate.groups [prerequisites and measures applied such in order to avoid confusion.at critical control points (CCP’s)] in a logical 2) No, PRP’s are not selected to controlorder for the development, implementation Early feedback indicates hazards identified through hazardand control of the food safety management that one should start by analysis – this will require specificsystem. Control measures are grouped into investing in the HACCP control measures assigned to operationalthree groups, as follows : skills revisited by ISO 22000 PRP’s or to the HACCP plan – but to create a suitable hygienic environment• prerequisite programmes (PRP’s) that that is able to keep to a minimum the manage the basic conditions and activities ; Early feedback on the use of likelihood of contamination. the standard indicates that the PRP’s are not selected for the one should start by investing purpose of controlling specific identified For further guidance, the author recommends in the HACCP skills revisited hazards but for the purpose of maintaining establishing contact with an expert in by ISO 22000 in order to reap a hygienic production, processing and/or the full benefits of the new another company, or a consultant or auditor, handling environment standard. Once these skills are and visiting Internet forums, specialized (see 7.2 of ISO 22000:2005) ; in place and operational, the clubs and FAQ’s. rest should follow as a matter• operational prerequisite programmes of course. • (operational PRP’s) that manage those ISO Management Systems – May-June 2006 11